DIA 2024 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-594-L04-P; CME 1.00; RN 1.00

Since establishment in 1990, the International Council for Harmonisation (ICH) has expanded its global footprint to harmonize requirements for the development of medicines and increase patient access to medicines. Importantly, ICH’s quality portfolio serves to support continual improvement and innovation in biopharmaceutical manufacturing. In 2018, ICH published its quality mission to “develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science.” The Q12 and Q14 Guidelines on Lifecycle Management and Analytical Procedure Development have been instrumental in advancing this mission. Previously, divergent requirements for filing post-approval changes presented challenges and in some cases, led to lengthy timelines for implementing process improvements or incorporating new technologies that may perform more efficiently. The Q12 framework offers a solution to facilitate a globally-aligned risk-based approach to post-approval change management allowing for more efficiency and better serving patient’s interest. Q14 provides additional considerations regarding lifecycle management for analytical procedures. While both of these guidelines are now finalized, there is still work to do to achieve the full benefits envisioned. With ICH’s expansion, it has prioritized the adequate implementation and adherence of guidelines through its work to promote training and periodically conduct a survey to assess guideline implementation by its Members and Observers. This session will provide global regulatory and industry perspective regarding progress made and future opportunities to achieve greater harmonization and encourage the global community to embrace the science and risk-based approaches envisioned by Q12 and Q14. Case studies will be presented highlighting the objectives and work to facilitate a globally aligned approach to implementation of these guidelines.

Learning Objectives

Analyze the objectives of ICH Guidelines Q12 Lifecycle Management and Q14 Analytical Procedure Development to promote innovation and facilitate more efficient post-approval change management; Examine status of implementation of Q12 and Q14 Guidelines globally; Investigate opportunities to advance global harmonization and more efficient lifecycle management by using case studies.

Chair

Amanda Marie Roache, MS

Speaker

Lifecycle Strategies at the Interface Between ICH Q12 and ICH Q14
Connie Langer, MSc

ICH Q14: Analytical Procedure Development and Lifecycle Management
Nina S. Cauchon, PhD

Update from Japan on Q12
Satomi Yagi

Update from EMA
Evdokia Korakianiti, PhD, MSc